NCT01199133

Safety and Efficacy Study of Sublingual Immunotherapy (SLIT) to Treat House Dust Mite Allergic Rhinitis in Adolescents and Children

A Randomised,Double-blind,Placebo-controlled,Multi National,Phase III Trial to Assess the Efficacy and Safety of 300 IR Sublingual Immunotherapy Administered as Allergen-based Tablets Once Daily to Adolescents and Children Above the Age of 5 Years, Suffering From House Dust Mite Allergic Rhinitis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 471 (actual)
• Sponsor: Stallergenes Greer · Industry
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy of one dose of sublingual immunotherapy (SLIT) administered to children and adolescents as allergen-based tablets once daily over a period of 24 months over 3 years compared to placebo, for reduction of allergic rhinitis symptoms and rescue medication use.

Detailed description

After the screening period, the patients will be administered 300 IR house dust mite allergen based tablets or placebo, once a day, for a period of 36 months with two windows of 8 months and 6 months without treatment. The carry over effect will be evaluated after a treatment free follow up period of 24 months. An independent Data Monitoring Committee will be constituted to evaluate the efficacy and safety data at the end of Year 1 and Year 3, and the post-treatment long-term efficacy data at the end of year 4.

Conditions

• Allergic Rhinitis Due to Dust Mite

Interventions

Type	Name	Description
DRUG	300 IR house dust mites allergen extract tablet	One sublingual tablet daily for one year.
DRUG	Placebo tablet	One sublingual tablet daily for one year.

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-01-01
• Completion: 2011-09-01
• First posted: 2010-09-10
• Last updated: 2025-02-11
• Results posted: 2025-02-11